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Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

Health Highlights: July 26, 2016

Posted yesterday in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Fixed Payments for Heart Attack Treatment Proposed by Medicare Fixed payments to hospitals for treating heart attack patients have been proposed by Medicare. Under the program, hospitals that treat heart attack patients would be offered a target price for all services provided in the hospital and within 90 days...

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FDA Updates Warnings for Fluoroquinolone Antibiotics

Posted today in Pharma Industry News

July 26, 2016 -- The U.S. Food and Drug Administration today approved safety labeling changes for a class of antibiotics, called fluoroquinolones, to enhance warnings about their association with disabling and potentially permanent side effects and to limit their use in patients with less serious bacterial infections. “Fluoroquinolones have risks and benefits that should be considered very carefully,” said Edward Co...

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Transgender's Classification as 'Mental Disorder' Is Outdated, Study Finds

Posted today in Medical

TUESDAY, July 26, 2016 -- Being transgender is currently classified as a mental health disorder in the World Health Organization International Classification of Diseases (ICD), but a new study suggests that should change. And, such a change wouldn't be without precedent. The American Psychiatric Association removed gender identity disorder from the latest edition of its Diagnostic and Statistical Manual of Mental...

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Menopause Hastens Aging, Studies Suggest

Posted today in Medical

TUESDAY, July 26, 2016 -- Menopause, and the insomnia that often goes along with it, can speed aging in women, two new studies suggest. "For decades, scientists have disagreed over whether menopause causes aging or aging causes menopause," said Steve Horvath, senior author of both papers. "It's like the chicken or the egg: which came first? Our study is the first to demonstrate that menopause makes you age...

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2 in 10 Alzheimer's Cases May Be Misdiagnosed

Posted today in Medical

TUESDAY, July 26, 2016 -- Alzheimer's disease is often misdiagnosed, possibly causing undue stress for those who don't have the disease but are told they do, and delays in treatment for others, two new studies reveal. Although no cure or effective treatment for Alzheimer's disease exists, a correct diagnosis is essential because some drugs can delay its progress and help preserve quality of life for as long as...

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FDA Bolsters Warnings About Class of Antibiotics

Posted today in Medical

TUESDAY, July 26, 2016 -- The U.S. Food and Drug Administration announced Tuesday that it's strengthening label warnings on a class of antibiotics called fluoroquinolones because the drugs can lead to disabling side effects, including long-term nerve damage and ruptured tendons. The agency also cautioned that these bacteria-fighting drugs -- including levofloxacin (Levaquin) and ciprofloxacin (Cipro) -- shouldn't...

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AbbVie Receives U.S. FDA Approval of Once-Daily Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the Treatment of Genotype 1 Chronic Hepatitis C

Posted yesterday in New Drug Approvals

NORTH CHICAGO, Ill., July 25, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) extended-release tablets. Viekira XR is a once-daily, extended-release co-formulation of the active ingredients in Viekira Pak...

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Ocular Therapeutix Receives Complete Response Letter from FDA for its NDA for Dextenza for the Treatment of Post-Surgical Ocular Pain

Posted 2 days ago in New Drug Applications

BEDFORD, Mass.--(BUSINESS WIRE)--Jul. 25, 2016-- Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Dextenza (dexamethasone...

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Valeant Pharmaceuticals Receives FDA Complete Response Letter for Latanoprostene Bunod

Posted 5 days ago in New Drug Applications

LAVAL, Quebec, July 22, 2016 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024%, an intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or...

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Puma Biotechnology Submits New Drug Application for PB272 (Neratinib) to FDA for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer

Posted 6 days ago in New Drug Applications

LOS ANGELES, Calif., July 21, 2016 - Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead product candidate PB272 (neratinib) for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab (Herceptin®)-based ...

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Merck Provides Regulatory Update on Biologics Licensing Application for Investigational Agent Bezlotoxumab

Posted 6 days ago in New Drug Applications

KENILWORTH, N.J.--(BUSINESS WIRE) July 21, 2016 --Merck (NYSE: MRK), known as MSD outside the United States and Canada, today said that the U.S. Food and Drug Administration (FDA) has requested the submission of new data and analyses from the MODIFY I and MODIFY II clinical trials previously submitted to the pending Biologics Licensing Application (BLA) for bezlotoxumab, an investigational agent for prevention of...

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Valeant and Progenics Announce FDA Approves Relistor Tablets for the Treatment of Opioid-Induced Constipation in Adults with Chronic Non-Cancer Pain

Posted 8 days ago in New Drug Approvals

LAVAL, Quebec and TARRYTOWN, N.Y., July 19, 2016 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE & TSX: VRX) and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced that the U.S. Food and Drug Administration has approved Relistor (methylnaltrexone bromide) Tablets for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain. Valeant expects to...

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FDA Advisory Committee Recommends Approval Of Brodalumab For Treatment Of Moderate-To-Severe Plaque Psoriasis

Posted 8 days ago in New Drug Applications

LAVAL, Quebec, July 19, 2016 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today announced that the Dermatologic and Ophthalmic Drugs Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) has voted by a margin of 18 to 0 for the approval of brodalumab injection, 210 mg, for adult patients with moderate-to-severe plaque psoriasis with conditions related to...

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Eisai Inc. and Arena Pharmaceuticals Announce FDA Approval of Belviq XR (lorcaserin HCl) Extended-Release Tablets

Posted 8 days ago in New Drug Approvals

WOODCLIFF LAKE, N.J. and SAN DIEGO, July 19, 2016 /PRNewswire/ -- Eisai Inc. and Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Belviq XR (lorcaserin HCl) CIV extended-release 20 mg tablets. The new formulation of lorcaserin will offer patients a once-a-day dosing option that may help them achieve and...

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FDA Expands Indication For Type 2 Diabetes Treatment Synjardy (Empagliflozin/Metformin Hydrochloride) To Include Treatment-Naïve Adults

Posted 8 days ago in New Drug Approvals

RIDGEFIELD, Conn., and INDIANAPOLIS, July 19, 2016 /PRNewswire/ -- The U.S. Food and Drug Administration has approved an expanded indication for Synjardy (empagliflozin and metformin hydrochloride) tablets to include treatment-naïve adults with type 2 diabetes (T2D). Synjardy, from Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY), is indicated as an adjunct to diet and exercise to improve glycemic control ...

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U.S. FDA Approves Prezista (darunavir) for Use in Pregnant Women with HIV

Posted 9 days ago in New Drug Approvals

TITUSVILLE, N.J., July 18, 2016 /PRNewswire/ -- Janssen Therapeutics, Division of Janssen Products, LP (Janssen), today announced that the U.S. Food and Drug Administration (FDA) has approved an expansion to the Prezista (darunavir) U.S. Prescribing Information to include data and results from a study investigating the use of Prezista during pregnancy and the postpartum period. A human immunodeficiency virus (HIV-1)...

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FDA approves first absorbable stent for coronary artery disease

Posted 3 weeks ago in Pharma Industry News

July 5, 2016 -- The U.S. Food and Drug Administration today approved the first fully absorbable stent to treat coronary artery disease. The Absorb GT1 Bioresorbable Vascular Scaffold System (BVS), which releases the drug everolimus to limit the growth of scar tissue, is gradually absorbed by the body in approximately three years. “The FDA’s approval of the Absorb GT1 BVS offers a new treatment option for ind...

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Monthly News Roundup - June 2016

Posted 3 weeks ago in Pharma Industry News

Epclusa: First Approval For All Major Forms of Chronic Hepatitis C Virus The U.S. Food and Drug Administration (FDA) has given the go-ahead to Epclusa (sofosbuvir and velpatasvir), a nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination for the treatment of chronic hepatitis C virus (HCV) infection in adults. Epclusa is used for HCV genotypes 1 through 6, with or without...

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FDA clears first test to detect specific genetic markers for certain antibiotic-resistant bacteria directly from clinical specimens

Posted 3 weeks ago in Pharma Industry News

June 29, 2016 -- The U.S. Food and Drug Administration today cleared for marketing the Xpert Carba-R Assay, an infection control aid that tests patient specimens to detect specific genetic markers associated with bacteria that are resistant to Carbapenem antibiotics. Carbapenem antibiotics are widely used in hospitals to treat severe infections. These resistant organisms are commonly referred to as...

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FDA approves implantable device that changes the shape of the cornea to correct near vision

Posted 3 weeks ago in Pharma Industry News

June 29, 2016 -- The U.S. Food and Drug Administration today approved the Raindrop Near Vision Inlay, a device implanted in the cornea (the clear, front surface) of one eye to improve near vision in certain patients with presbyopia. It is the second FDA-approved implantable corneal device for correction of near vision in patients who have not had cataract surgery and the first implantable device that changes the...

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Pfizer Announces the Publication of Final Results from Two Pivotal Phase 3 Studies of Crisaborole Topical Ointment in Patients with Mild to Moderate Atopic Dermatitis

Posted 2 weeks ago in Clinical Trials

July 13, 2016 - Pfizer Inc. (NYSE:PFE) announced today the publication of findings from two pivotal Phase 3 studies of investigational crisaborole topical ointment 2% (formerly AN2728) in the online issue of the Journal of the American Academy of Dermatology. “Atopic dermatitis, or eczema, is a chronic, inflammatory skin disease that affects millions of children and adults. There have been no new therapies a...

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Lilly And Boehringer Ingelheim Announce Clinical Trial Collaboration In Metastatic Breast Cancer

Posted 2 weeks ago in Clinical Trials

INDIANAPOLIS, July 13, 2016 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Boehringer Ingelheim today announced a new collaboration on a Phase 1b study that will evaluate the safety and tolerability of abemaciclib (LY2835219), Lilly's cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor, in combination with BI 836845, Boehringer Ingelheim's insulin-like growth factor (IGF)-1/IGF-2 ligand neutralizing antibody,...

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AbbVie Receives U.S. FDA Rare Pediatric Disease Designation for Investigational ABT-414 for the Treatment of a Type of Pediatric Brain Tumor known as Diffuse Intrinsic Pontine Glioma (DIPG)

Posted 2 weeks ago in Clinical Trials

NORTH CHICAGO, Ill., July 11, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation for ABT-414, an investigational antibody drug conjugate (ADC) targeting the epidermal growth factor receptor (EGFR), for the treatment of pediatric patients with EGFR-amplified Diffuse Intrinsic Pontine...

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Revive Therapeutics Ltd. Announces US FDA Acceptance of IND of Bucillamine for the Treatment of Cystinuria

Posted 3 weeks ago in Clinical Trials

TORONTO, ONTARIO--(Marketwired - July 6, 2016) - Revive Therapeutics Ltd. ("Revive" or the "Company") (TSX VENTURE:RVV)(OTCQB:RVVTF), a company focused on commercializing treatments for rare diseases such as Cystinuria, Wilson's disease and Rett Syndrome, today announced that the U.S. Food and Drug Administration ("US FDA") has accepted the Company's Investigational New Drug Application ("IND") for a Phase 2...

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Merck KGaA, Darmstadt, Germany, and Pfizer Initiate Phase III Trial to Evaluate Avelumab as First-line Treatment for Ovarian Cancer

Posted 3 weeks ago in Clinical Trials

July 6, 2016 Merck KGaA, Darmstadt, Germany, and Pfizer (NYSE: PFE) today announced the initiation of a Phase III study, JAVELIN Ovarian 100, to evaluate the efficacy and safety of avelumab* in combination with, and/or as follow-on (maintenance) treatment to, platinum-based chemotherapy in patients with locally advanced or metastatic disease (Stage III or Stage IV) with previously untreated epithelial ovarian...

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